PMID- 29477308
OWN - NLM
STAT- MEDLINE
DCOM- 20180907
LR  - 20180907
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 36
IP  - 13
DP  - 2018 Mar 20
TI  - Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in 
      the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.
PG  - 1781-1788
LID - S0264-410X(18)30208-1 [pii]
LID - 10.1016/j.vaccine.2018.02.034 [doi]
AB  - BACKGROUND: The Food and Drug Administration (FDA) approved quadrivalent human 
      papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, 
      since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse 
      Event Reporting System (VAERS), a US spontaneous reporting system, in females and 
      males who received 4vHPV vaccination. METHODS: We searched VAERS for US reports 
      of adverse events (AEs) following 4vHPV from January 2009 through December 2015. 
      Signs and symptoms were coded using Medical Dictionary for Regulatory Activities 
      (MedDRA). We calculated reporting rates and conducted empirical Bayesian data 
      mining to identify disproportional reports. Clinicians reviewed available 
      information, including medical records, and reports of selected pre-specified 
      conditions. FINDINGS: VAERS received 19,760 reports following 4vHPV; 60.2% in 
      females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports 
      were non-serious; dizziness, syncope and injection site reactions were commonly 
      reported in both males and females. Headache, fatigue and nausea were commonly 
      reported serious AEs. More than 60 million 4vHPV doses were distributed during 
      the study period. Crude AE reporting rates were 327 reports per million 4vHPV 
      doses distributed for all reports, and 19 per million for serious reports. Among 
      29 verified reports of death, there was no pattern of clustering of deaths by 
      diagnosis, co-morbidities, age, or interval from vaccination to death. 
      INTERPRETATION: No new or unexpected safety concerns or reporting patterns of 
      4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is 
      consistent with data from pre-licensure trials and postmarketing safety data.
CI  - Published by Elsevier Ltd.
FAU - Arana, Jorge E
AU  - Arana JE
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States. Electronic address: JArana@cdc.gov.
FAU - Harrington, Theresa
AU  - Harrington T
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Mba-Jonas, Adamma
AU  - Mba-Jonas A
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, US Food and Drug Administration, United 
      States.
FAU - Rongxia, Li
AU  - Rongxia L
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Stewart, Brock
AU  - Stewart B
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Markowitz, Lauri E
AU  - Markowitz LE
AD  - Division of Viral Diseases, National Center for Immunization and Respiratory 
      Diseases, Centers for Disease Control and Prevention, United States.
FAU - Shimabukuro, Tom T
AU  - Shimabukuro TT
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
LA  - eng
PT  - Journal Article
DEP - 20180221
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Alphapapillomavirus/*immunology
MH  - Bayes Theorem
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Male
MH  - Papillomavirus Infections/*epidemiology/*prevention & control
MH  - Papillomavirus Vaccines/*adverse effects/*immunology
MH  - *Product Surveillance, Postmarketing
MH  - Public Health Surveillance
MH  - United States/epidemiology
MH  - Vaccination
MH  - Young Adult
OTO - NOTNLM
OT  - Immunization
OT  - Quadrivalent human papillomavirus vaccine (4vHPV)
OT  - Vaccination
OT  - Vaccine Adverse Event Reporting System (VAERS)
OT  - Vaccine safety
EDAT- 2018/02/27 06:00
MHDA- 2018/09/08 06:00
CRDT- 2018/02/26 06:00
PHST- 2017/04/21 00:00 [received]
PHST- 2017/10/16 00:00 [revised]
PHST- 2018/02/05 00:00 [accepted]
PHST- 2018/02/27 06:00 [pubmed]
PHST- 2018/09/08 06:00 [medline]
PHST- 2018/02/26 06:00 [entrez]
AID - S0264-410X(18)30208-1 [pii]
AID - 10.1016/j.vaccine.2018.02.034 [doi]
PST - ppublish
SO  - Vaccine. 2018 Mar 20;36(13):1781-1788. doi: 10.1016/j.vaccine.2018.02.034. Epub 
      2018 Feb 21.